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FDA 510(k)

Patient-Specific Airway Stent

K-Number: K182743 · 2019-10-23

ApplicantNew Cos, Inc.
Decision Date2019-10-23
Product CodeNWA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Patient-Specific Airway Stent is a medical device manufactured by New Cos, Inc.. It received FDA 510(k) clearance on 2019-10-23 under approval number K182743. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient-Specific Airway Stent?

Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2019-10-23. It is manufactured by New Cos, Inc.. The 510(k) number is K182743.

When was Patient-Specific Airway Stent approved by the FDA?

Patient-Specific Airway Stent received FDA 510(k) clearance on 2019-10-23, under approval number K182743.

What company makes Patient-Specific Airway Stent?

Patient-Specific Airway Stent is manufactured by New Cos, Inc..

What is the FDA product code for Patient-Specific Airway Stent?

The FDA product code for Patient-Specific Airway Stent is NWA.

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

Related Devices (Code: NWA)

K213969VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions K243126TRACHEOBRONXANE™ DUMON®Novatech SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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